Nicotine ExposurePhase 1NCT04155697
Thirdhand Smoke Contamination in a Neonatal Intensive Care Unit (NICU)
A Phase 1 study testing 2% Chlorohexidine Gluconate soap and 62% ethyl alcohol-based hand sanitizer in people with Nicotine Exposure, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of the study is to quantify the efficacy of hand washing (HW) and ethyl alcohol-based hand sanitizer (S) for third-hand smoke (THS) removal in a sub-sample of non-staff smokers using nicotine wipes on adjacent fingers before and after HW/S. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nicotine Exposure
- What is being tested?
- 2% Chlorohexidine Gluconate soap and 62% ethyl alcohol-based hand sanitizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2017to 11 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Any non-staff participants visiting the NICU (including friends and family members of the infants' caregivers)
- Consented to and provided a finger wipe
- Report being a smoker
- Smoking status verified by an exhaled carbon monoxide (CO) level of >7 parts per million
Who cannot join
- Unwilling to comply with research procedures (i.e., finger wipes)
- Does not speak English.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of the study is to quantify the efficacy of hand washing (HW) and ethyl alcohol-based hand sanitizer (S) for third-hand smoke (THS) removal in a sub-sample of non-staff smokers using nicotine wipes on adjacent fingers before and after HW/S.
The hypotheses are that detectable levels of surface nicotine will remain on participants' fingers, regardless of hand washing (HW) and ethyl alcohol-based hand sanitizer (S) attempts and that greater finger levels of surface nicotine will remain after alcohol sanitization compared to hand washing.
- Conditions
- Nicotine Exposure
- Being tested
- 2% Chlorohexidine Gluconate soap, 62% ethyl alcohol-based hand sanitizer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% Chlorohexidine Gluconate soapDrug
Participants will wash hands for 30 seconds with 2% Chlorohexidine Gluconate soap.
62% ethyl alcohol-based hand sanitizerDrug
Participants will apply 62% ethyl alcohol-based hand sanitizer for 30 seconds
| Study group | Role | What they receive |
|---|---|---|
| Hand washing with soap for thirdhand smoke removal | Active comparator | Not described Receives: Drug: 2% Chlorohexidine Gluconate soap |
| Ethyl alcohol-based sanitizer for thirdhand smoke removal | Active comparator | Not described Receives: Drug: 62% ethyl alcohol-based hand sanitizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine level on finger #1
Nicotine will be sampled from one finger of each participant's dominant hand (thumb, index, or middle finger). Finger will be wiped and nicotine level will be quantified.
Measured: baseline
Nicotine level on finger #2
Nicotine will be sampled from one finger of each participant's dominant hand (thumb, index, or middle finger). Finger will be wiped and nicotine level will be quantified.
Measured: 5 minutes after hand washing or sanitizing
Nicotine level on finger #3
Nicotine will be sampled from one finger of each participant's dominant hand (thumb, index, or middle finger). Finger will be wiped and nicotine level will be quantified.
Measured: 1 hour after hand washing or sanitizing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start7 Jun 2017
- Primary completion11 Sep 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine ExposureStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Thomas Francis Northrup, The University of Texas Health Science Center, Houston
- Investigators
- Thomas Northrup, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155697
- Sponsor's protocol ID
- HSC-MS-15-0614 (sub-study)
- Other IDs
- R03HD088847
- Status last verified
- May 2022
- First submitted
- 5 Nov 2019
- Last updated
- 9 May 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Northrup TF, Stotts AL, Suchting R, Khan AM, Klawans MR, Green C, Hoh E, Hovell MF, Matt GE, Quintana PJE. Handwashing Results in Incomplete Nicotine Removal from Fingers of Individuals who Smoke: A Randomized Controlled Experiment. Am J Perinatol. 2022 Nov;39(15):1634-1642. doi: 10.1055/s-0041-1736287. Epub 2021 Oct 11.
PubMed 34634832
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thirdhand Smoke Contamination in a Neonatal Intensive Care Unit (NICU)
- ClinicalTrials.gov ID
- NCT04155697
- Acronym / sponsor ID
- HSC-MS-15-0614 (sub-study)
- Conditions
- Nicotine Exposure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to quantify the efficacy of hand washing (HW) and ethyl alcohol-based hand sanitizer (S) for third-hand smoke (THS) removal in a sub-sample of non-staff smokers using nicotine wipes on adjacent fingers before and after HW/S.
The hypotheses are that detectable levels of surface nicotine will remain on participants' fingers, regardless of hand washing (HW) and ethyl alcohol-based hand sanitizer (S) attempts and that greater finger levels of surface nicotine will remain after alcohol sanitization compared to hand washing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand washing with soap for thirdhand smoke removal | Active comparator | Drug: 2% Chlorohexidine Gluconate soap |
| Ethyl alcohol-based sanitizer for thirdhand smoke removal | Active comparator | Drug: 62% ethyl alcohol-based hand sanitizer |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Any non-staff participants visiting the NICU (including friends and family members of the infants' caregivers)
- Consented to and provided a finger wipe
- Report being a smoker
- Smoking status verified by an exhaled carbon monoxide (CO) level of >7 parts per million
Key exclusion criteria (2 listed)
- Unwilling to comply with research procedures (i.e., finger wipes)
- Does not speak English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% Chlorohexidine Gluconate soapParticipants will wash hands for 30 seconds with 2% Chlorohexidine Gluconate soap. | Drug | Hand washing with soap for thirdhand smoke removal |
| 62% ethyl alcohol-based hand sanitizerParticipants will apply 62% ethyl alcohol-based hand sanitizer for 30 seconds | Drug | Ethyl alcohol-based sanitizer for thirdhand smoke removal |
Primary outcome
Nicotine level on finger #1
Time frame: baseline
Nicotine will be sampled from one finger of each participant's dominant hand (thumb, index, or middle finger). Finger will be wiped and nicotine level will be quantified.
Nicotine level on finger #2
Time frame: 5 minutes after hand washing or sanitizing
Nicotine will be sampled from one finger of each participant's dominant hand (thumb, index, or middle finger). Finger will be wiped and nicotine level will be quantified.
Nicotine level on finger #3
Time frame: 1 hour after hand washing or sanitizing
Nicotine will be sampled from one finger of each participant's dominant hand (thumb, index, or middle finger). Finger will be wiped and nicotine level will be quantified.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Derived from this study: PubMed 34634832Northrup TF, Stotts AL, Suchting R, Khan AM, Klawans MR, Green C, Hoh E, Hovell MF, Matt GE, Quintana PJE. Handwashing Results in Incomplete Nicotine Removal from Fingers of Individuals who Smoke: A Randomized Controlled Experiment. Am J Perinatol. 2022 Nov;39(15):1634-1642. doi: 10.1055/s-0041-1736287. Epub 2021 Oct 11.
- Individual participant dataSharing planned: No
Related trials for Nicotine Exposure
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Recruiting
Brain/Craving Response to Smoking Cues After Oral Nicotine Pouch Use
Nicotine Dependence
Recruiting
Melanin and Dermal Uptake of Thirdhand Cigarette Smoke
Healthy
Recruiting
The "Quit-for-Kids" Project: to Increase Abstinence and Protect Children From Tobacco Smoke Exposure
Smoking Cessation, Second Hand Tobacco Smoke
Recruiting
Neuroimaging Approaches to Improve Prediction of Smoking Initiation and Nicotine Escalation in Young Adult ENDS Users
Message Exposure (Sequence: Regular Then Flavor), Message Exposure (Sequence: Flavor Then Regular)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Northrup, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 2% Chlorohexidine Gluconate soap and 62% ethyl alcohol-based hand sanitizer in people with Nicotine Exposure, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nicotine level on finger #1 (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04155697, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.